Implants and methods for treating charcot foot and other conditions

ABSTRACT

A fixation system for immobilizing a skeletal structure is provided. It includes an internal fixation system having a rod-plate subsystem, a shaft subsystem, and a midfoot plate subsystem. It further includes an external fixation system adapted to connect to the internal fixation system and having a sole that provides a weight-bearing platform underneath a patient&#39;s foot to enable a patient to walk with the fixation system.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a national phase filing under 35 U.S.C. § 371of International Patent Application No. PCT/US219/016257 filed on Feb.1, 2019, which claims the benefit of U.S. Provisional Application Ser.No. 62/626,324, filed Feb. 5, 2018, the disclosure of which is expresslyincorporated herein by reference in its entirety.

TECHNICAL FIELD

The present invention relates to implants and methods for the treatmentof various medical conditions typically involving mammalian extremities.One such condition is a human extremity deformity known as Charcot foot.

BACKGROUND

The terminology and descriptions contained herein are principally withinthe art field of, and for those skilled in the art of, orthopedicmedicine. As such, only brief explanations of known subject matterwithin this art field will be provided because the details will be wellknown to those skilled in this art. The present invention, however, willbe thoroughly described.

Damage or dysfunction of peripheral nerves of the foot causing numbnessor weakness, also known as neuropathy, can lead to a condition known asCharcot arthropathy, or more commonly referred to as Charcot foot. Morespecifically, when a patient with neuropathy has an injury to theirfoot, the neuropathy may prevent them from sensing the injury. Withoutthis defense mechanism which would otherwise cause the patient to feelpain, avoid continued injury and/or seek medical attention, the patientwill continue to walk on the injured foot. This typically exacerbatesthe injury and affects surrounding areas of the foot, ultimately leadingto possible deformity, disability, and even amputation of the foot inextreme cases.

One common symptom of advanced Charcot foot is the collapse of certainjoints in the foot and a resulting disfigurement of the foot. Surgicaltreatment often involves the re-alignment and fixation of various boneswithin the foot to correct such deformity.

Various general internal fixation systems involving screws, plates,bolts, nails, and the like, are known and available for use to correctCharcot foot deformities. Similarly, various general external fixationsystems involving external frames, pins, wires, screws, and the like,are also known and available for use to correct Charcot footdeformities. Some of the challenges in the art are constructing acustomized patient solution to Charcot foot that includes internalfixation interacting with external fixation, and providing aweight-bearing platform for the affected limb, enabling a patient towalk soon after surgical intervention. The present invention offerssolutions to these challenges and contemplates various novel andnon-obvious combinations of implant modularity, interaction betweeninternal and external fixation systems, and a weight-bearing platform.

SUMMARY OF THE INVENTION

A fixation system is provided for immobilizing a skeletal structure, thefixation system having an internal fixation system with one or more of arod-plate system and a shaft system, and an external fixation system.The rod-plate system includes a rod affixed to a plate, the rod beingadapted to be positioned in a bone canal, and the plate being adapted tobe positioned on bone near the bone canal. The shaft system includes ashaft with a longitudinal axis, a slot on the shaft oriented in thedirection of the longitudinal axis, and a hole on the shaft oriented atan angle to the longitudinal axis, the shaft further adapted to bepositioned in a bone canal and configured to move two bone segments thatcomprise the bone canal toward each other. The external fixation systemcomprises a frame connected to a sole, the sole having a bottom adaptedto contact ground.

The external fixation system further includes a pin to connect therod-plate system or the shaft system to the external fixation systemwhen the rod-plate system or the shaft system is located in bone.Optionally, the rod-plate system may be connected to the shaft systemwhen both systems are located in bone. The rod of the rod-plate systemcan be modularly comprised of multiple segments that are joinable by aconnection. This connection can be a threaded connection or aMorse-taper connection. The plate of the rod-plate system includes afirst side adapted to face bone, an opposite second side, a length, awidth, a plate axis along the length, and a projection extending fromthe first side. This projection has an opening to communicate with therod of the rod-plate system. This opening communicates with the rod viaa threaded connection. The opening is cylindrical and has a longitudinalopening axis, where the opening is oriented such that the opening axisis at an angle to the plate axis. Finally, the shaft of the shaft systemcan be modularly comprised of multiple segments each joinable at aconnection. The fixation system can also include a midfoot plate systemattached to bone, where the midfoot plate system comprises a plate andfasteners to attach the plate to bone.

Another embodiment of the fixation system that is provided forimmobilizing a skeletal structure comprises an internal fixation systemhaving a rod-plate system, a shaft system and an external fixationsystem. The rod-plate system includes a rod affixed to a plate, the rodbeing adapted to be positioned in a bone canal, and the plate beingadapted to be positioned on bone near the bone canal, where the platefurther includes a first side adapted to face bone, an opposite secondside, a length, a width, a plate axis along the length, and a projectionextending from the first side. This projection has a cylindrical openingwith a longitudinal opening axis, where the opening is oriented suchthat the opening axis is at an angle to the plate axis. The rod-platesystem is connected to the shaft system with at least one fixationelement when both systems are located in bone, and the external fixationsystem may also be connected to one of the rod-plate system or shaftsystem.

Another embodiment of a fixation system is provided for immobilizing askeletal structure, this fixation system having an internal fixationsystem including one or more of a rod-plate system and a shaft system,and an external fixation system.

The rod-plate system includes a rod affixed to a plate, the rod beingadapted to be positioned in a bone canal, and the plate being adapted tobe positioned on bone near the bone canal. The shaft system includes ashaft with a longitudinal axis, a slot on the shaft oriented in thedirection of the longitudinal axis, and a hole on the shaft oriented atan angle to the longitudinal axis. The shaft is further adapted to bepositioned in a bone canal and configured to move at least two bonesegments through which the bone canal passes, toward each other. Theexternal fixation system includes a frame connected to a sole, the solehaving a housing and a bottom adapted to contact ground, where thehousing contains a liner. The liner also includes an inflatable bladderin a shell. The sole can be connected to the frame with adjustablestruts. The rod of the rod-plate system is modularly comprised ofmultiple segments each joinable by a connection, where the connection iseither a threaded connection, a Morse-taper connection, or other type ofconnection.

The external fixation system further includes at least one pin toconnect the external fixation system to either the rod-plate system orshaft system, and a frame connected to a sole, where the sole has abottom adapted to contact ground. The fixation system can also include amidfoot plate system attached to bone, the midfoot plate systemcomprising a plate and a fastener.

Other features of the present invention will become more apparent aftera review of the Detailed Description and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing features of the invention will be apparent from thefollowing Detailed Description, taken in connection with theaccompanying drawings, in which:

FIG. 1 is a perspective view of a fully assembled fixation system of apreferred embodiment of the present invention incorporating internalfixation, external fixation, and a weight bearing platform;

FIG. 1A is a perspective view of a human foot;

FIG. 2 is a side elevational view of a rod component of the internalfixation system shown in FIG. 1;

FIG. 3 is a side elevational view of an intrabody connection mechanismfacilitating modularity of the rod component of the internal fixationsystem;

FIG. 4 is a side elevational view of an alternative connection mechanismto that shown in FIG. 3;

FIG. 5 is a side elevational view of an alternative end of the rodcomponent;

FIG. 6 is a top view of a connection plate component of the internalfixation system shown in FIG. 1;

FIG. 7 is a side elevational view of the connection plate component;

FIG. 8 is a top view of an alternate embodiment of the connection platecomponent;

FIG. 9 is a side elevational view of the connection plate componentshown in FIG. 8;

FIG. 10 is a front exploded view of the connection plate component shownin FIG. 8 with several fasteners to be used to attach the platecomponent to bone;

FIG. 11 is a cross-sectional view of the connection plate componentshown in FIG. 8 taken along section line 11-11, connected with the rodcomponent of FIG. 2, which is also shown in cross-section forconsistency;

FIG. 12 is a cross-sectional view similar to that of FIG. 11, butdepicting an alternative connection of the rod component to the platecomponent;

FIG. 13 is a top view depicting a human foot with several assembledrod-plate constructs of the internal fixation system;

FIG. 14 is a side elevational view of what is shown in FIG. 13;

FIG. 15 is an exploded elevational view of a shaft component of theinternal fixation system;

FIG. 16 is a partial exploded elevational view of the shaft component ofFIG. 15 shown assembled, along with several fasteners used to attach theshaft component to bone;

FIG. 17 is a side elevational view of a fully assembled shaft componentaffixed to two bones prior to reduction;

FIG. 17A is a side elevational view of what is shown in FIG. 17,depicting motions that reduce the space between the two bones;

FIG. 18 is a top view of two shafts implanted in a foot;

FIG. 19 is a side elevational view of what is shown in FIG. 18;

FIG. 20 is a top view of various internal fixation systems implanted ina foot, including plate-rod constructs, and rods connected to shafts;

FIG. 21 is a side elevational view of what is shown in FIG. 20;

FIG. 22 is a perspective view of a midfoot plate component of theinternal fixation system;

FIG. 23 is a top plan view of the midfoot plate component implanted in afoot along with the other internal fixation systems depicted in FIGS. 20and 21;

FIG. 24 is a top view of two shaft systems of the internal fixationsystem implanted in a foot and connected to an external fixation system;

FIG. 25 is a perspective view of a sole component that is part of theexternal fixation system; and

FIG. 26 is an exploded perspective view of various components of theexternal fixation system, including the sole component forming theweight bearing platform.

DETAILED DESCRIPTION

For convenience and efficiency of explanation only, the followingdescriptions of various embodiments of the present invention will beprovided with reference to a human foot. However, this part of the bodyis only meant to be exemplary, non-limiting, and facilitative of astraightforward explanation of the invention, since aspects of thepresent invention are also envisioned to apply to other skeletalstructures.

Referring to FIG. 1, a fixation system 10 for treating Charcot foot andother extremity deformities is depicted. Fixation system 10 comprises aninternal fixation system 40 and an external fixation system 80. Internalfixation system 40 is comprised of three general subsystems referred toas rod-plate system 50, shaft system 60, and midfoot plate system 70.External fixation system 80 relevantly includes an optionalweight-bearing platform, referred to as sole 400. The various systems,and certain of their various internal and external components, aremodular, and may be mixed, matched and used together or independently,as will be discussed in more detail below.

With reference to FIG. 1A, the human foot comprises the forefoot 12which includes the metatarsals 14 and phalanges 16, the midfoot 18 whichincludes the three cuneiform bones 20, the cuboid 22 and the navicularbone 24, and the hindfoot 26 which includes the talus 28 and calcaneus30. For the sake of conciseness, and because anatomy is well known tothose skilled in the art, further reference to the various parts of thefoot may be made herein without accompanying reference numbers.

Directional and spatial anatomical terminology that is also used hereinis similarly well known to those skilled in the art. For instance, theterm “medial” typically means closer to the midline of the body, and“lateral” typically means farther from the midline of the body. Furtherterms, such as “proximal”, “distal”, “anterior”, “posterior”,“superior”, “inferior”, and other such terms shall have their common andordinary meanings in the art.

As used herein, the terms “rod” and “shaft” are chosen to describe thelongitudinal members of the internal fixation system for convenience andefficiency of explanation only, and are not meant to be limiting. Thus,“rod” and “shaft” are intended to be non-limiting generic terms that mayinclude such things as a bolt, nail, screw, strut, beam and the like.

As an overview, FIGS. 2-14 depict components of rod-plate system 50,which is one of three subsystems of internal fixation system 40. FIGS.15-19 depict components of shaft system 60, which is the second of thethree subsystems of internal fixation system 40. FIGS. 22-23 depictmidfoot plate system 70, which is the third subsystem of internalfixation system 40. FIGS. 20, 21, and 23 depict various combinations ofthe various internal fixation subsystems. And FIGS. 24-26 depictcomponents of the external fixation system 80.

With reference to FIGS. 2-5, rod 100 includes a body 108 with a firstend 104 and a second end 106, which terminates at a flat surface 134. Asalternatively depicted in FIG. 5, second end 106 may terminate at arounded surface 136. As will be discussed later, rounded surface 136 isbetter suited to facilitating the insertion of rod 100 into a bonecanal.

Rod 100 may be unitary and continuous from end 104 to end 106, orcomprised of two or more joined segments, such as first segment 110joined at connection 102 to second segment 112. Connection 102 generallyrepresents various connection mechanisms that enable the joining of tworod segments together, and will be discussed in more detail, below.

Body 108 of rod 100 may have a generally circular transversecross-sectional shape or may have any other cross-sectional shape suchas oval, polygonal or otherwise, as may be suited for variousapplications. Body 108 may also be roughened, knurled, or otherwiseprovided with any other surface topography known in the art, for variouspurposes also known in the art, such as to provide an improved surfacefor bone adhesion. Furthermore, rod 100, or any of its segments, may besolid or hollow.

The first and second segments 110, 112 of rod 100 are joined together atconnection 102. FIG. 3 depicts a Morse taper-type connection, and FIG. 4depicts a threaded connection, both of which will be described in moredetail, below. Of course, other alternative connections are envisioned.It is further envisioned that in the case of multiple segments of a rod,the same type of connection, or different types of connections, may beemployed to join each two segments of a rod 100 together, depending on awide array of factors, as known to those skilled in the art. Similarly,if it is desired to use more than one rod 100 in an implantation, it isenvisioned that one segmented rod may be assembled with one type ofconnection and another segmented rod may be assembled with another typeof connection. The rationale for doing so may be due to, for example,the various details and advantages of one type of connection overanother, and the resultant properties of the assembled rods with thedifferent connection types.

As mentioned above, FIG. 3 depicts a Morse-taper type of connection.Second rod segment 112 has a male end 118. Male end 118 includes aconical shoulder 120 that tapers to a projection 122 having a smallerdiameter than body 108. First rod segment 110 has a female end 114comprising a conical opening 115 significantly decreasing in diameterand leading to an inner bore 116. In general, female end 114 isdimensioned to matingly receive male end 118. Thus, shoulder 120 has ageneral correspondence and sizing relationship to opening 115, andsimilarly, projection 122 to bore 116. More specifically, as is known inthe art of Morse tapers, one or both of male end 118's shoulder 120 andprojection 122 have circumferential dimensions that are slightly largerthan those of the corresponding female end 114's opening 115 and bore116. When male end 118 is inserted into female end 114, the interferencein dimensions results in a press-fit, locking second rod segment 112 tofirst rod segment 110.

If it is desired to not have a rotational preference to the axialalignment, or no keying effect, of first rod segment 110 to second rodsegment 112, then the Morse-taper mating surfaces described just abovewould all have circular cross sections. Of course, if a keying effectwould be desired, then the cross-sectional shapes of the mating surfacesmay be oval, polygonal, or any other shape known in the art.

FIG. 4, as an alternative embodiment, depicts a threaded connectionmechanism 102 between first rod segment 110 and second rod segment 112.Female end 114 of first rod segment 110 comprises a bore 123 withinternal threads 124. Male end 118 of second rod segment 112 comprises acorresponding projection 126 with external threads 128. Projection 126with external threads 128 is configured to be matingly received in athreaded fashion in threaded bore 123 of female end 114. When soassembled, first rod segment 110 is securely connected to second rodsegment 112.

With reference to FIG. 5, rod 100 may have one or more through-holes 130configured to receive a fastener (not shown), such as a bone screw, orother fastener known in the art. As will be evident to those skilled inthe art, through-hole 130 may be internally threaded so as to threadablyreceive a corresponding threaded fastener, or may be provided with anyother connection mechanism known in the art. In other embodiments,through-hole 130 is smooth and does not contain any form of connectionmechanism. Through-hole 130 can receive a fastener to facilitatefixation of rod 100 within the medullary canal within which rod 100 maybe positioned. Alternatively, through-hole 130 may receive a fastenerthat is also connected to one or more other rods 100 which themselvesmay be positioned and fixed relative to other human bones in the foot toprovide fixation across such bones. In yet other embodiments, hole 130may receive fixation elements from external fixation system 80.

Slot 132 is depicted on second end 106 of rod 100, and its length isoriented generally along the long axis of rod 100. The purpose andfunction of slot 132 will be discussed in more detail with reference toFIGS. 15-17A, where shaft 200 has a relatively similar slot 240.

With reference to FIG. 2, first end 104 of rod 100 includes a projection138 having external threads 140, and a shoulder 142. As will bedescribed in more detail below, projection 138, external threads 140,and shoulder 142 communicate with connection plate 150 (FIG. 11) to forman improved fixation construct. In other embodiments, connectionmechanisms other than threads are envisioned such as, for instance,interference fit, cross-screw (FIG. 12), nut-and-bolt, ratchetmechanism, and other connection methods known in the art.

In its contemplated embodiments, rod 100 may be formed of any suitablematerial known in the art, such as titanium, or other biocompatiblematerials having mechanical properties suitable for the contemplateduses of fixation system 10. Furthermore, rod 100 may be coated with anysuitable biocompatible coating known in the art, such as hydroxyapatiteor the like, or may be uncoated, as needed to suit particular mechanicaland clinical needs.

In the contemplated embodiments of the present invention, rods 100 maybe provided in various lengths and configured to provide axial stabilityto the bones in which they reside. In some embodiments, a rod 100 isconfigured to have a length such that the rod 100 extends from a portionof a metatarsal into the talus or calcaneus of the hindfoot to provideaxial stability. Rods 100 may also be provided in various diameters suchas, for instance, a diameter of about 3 mm, about 3.5 mm, about 4 mm,about 4.5 mm or any other diameter known in the art that is suitable forthe intended use of rod 100. As will be evident to one skilled in theart, the selection of one or more appropriately sized rods 100 may bemade by the surgeon in the operating room during surgery, or the rods100 may be selected and prepared prior to surgery.

FIGS. 6-12 depict embodiments of a connection plate component 150 thatare configured to facilitate connection between a rod, such as rod 100,and a bone, to improve the robustness and rigidity of an internalfixation construct of fixation system 10. As described in an exemplaryembodiment herein, plate 150 attaches to a metatarsal of a human foot.However, the description of plate 150 in the exemplary embodiment ispresented for convenience and efficiency of explanation only, and is notmeant to be taken as limiting the scope of the invention to theexemplary embodiment. In other embodiments, plate 150 may be fixed tobones other than the metatarsal of a human foot. For instance, plate 150may be fixed to a metacarpal bone of a human hand or to another humanbone. Plate 150 may be generally parallelogram, square, rectangular,oval, or any other shape known in the art that is suitable for fixationto the bone to which plate 150 is to be affixed.

Referring to FIGS. 6-12, plate 150 includes a first side 152, a secondside 154 opposite first side 152, a thickness T extending therebetween,and a perimeter edge 156. In an embodiment, plate 150 includes fourlobes 158 each having a lobe edge 160 adjacent lobe 158 and an aperture162 that extends through the thickness T of the plate 150. In otherembodiments, plate 150 may have more or fewer lobes 158, while in stillother embodiments, plate 150 may have four lobes, wherein lobes 158includes more or fewer apertures 162. Apertures 162 are configured toreceive fasteners, such as screws 164, and are generally circular inshape, however other shapes for one or more apertures 162 may be used,such as slots, for example. Apertures 162 include a first flared portion166 on first side 152 of plate 150 and a second flared portion 168 onsecond side 154 of plate 150. As will be understood by those skilled inthe art, second flared portions 168 are configured to receive a fastenerhead therein so that the fastener head may be partially or fullyrecessed within plate 150. Additionally, the combination of flaredportions 166, 168 together, enables for angular placement of a fixationelement, such as screw 164, through plate 150. In various embodiments,the flared portions 166, 168 include a gradual taper or conical shape, arecessed or step-down area, or a curved or rounded portion, or any otherflare known in the art to receive the head of a fastener. In otherembodiments, the flared portions 166, 168 may be omitted so thatapertures 162 extend perpendicular to thickness T. In such embodiments,fasteners without protruding heads can be used. Additionally, it isenvisioned that the one or more apertures 162 may be designed toaccommodate a snap ring (not shown) or other mechanism to prevent ascrew 164 from backing out of plate 150. Such back-out mechanisms arewell known in the art.

Referring to FIG. 6, embodiments of plate 150 may be of various shapesand configurations. Plate 150 includes a long axis A, a short axis C, alength L1 measured as the largest length along the long axis A, and awidth W1 measured as the largest width along the short axis C. The shapeof the exemplary plate 150 is generally a parallelogram, however theshape and configuration of plate 150 can be varied. For instance,reducing the length L1 or increasing the width W1 would result in aparallelogram shape that is shaped more like a square. In otherembodiments, length L1 can be increased and width W1 can be reducedresulting in a rectangularly shaped parallelogram having one pair ofopposing sides of perimeter edge 156 longer than the other pair.

The length L2 is the shortest distance between opposing sections ofperimeter wall 156 at the intersection of the long axis A and theperimeter wall 156, and width W2 is the shortest distance betweenopposing perimeter walls 156 at the intersection of the short axis C andthe perimeter wall 156. As depicted in FIG. 6, in an embodiment, thelength L2 and width W2 cooperate to provide a generally parallelogramshape. In some embodiments, the length L2 can be increased or reduced toprovide a shape that is more rectangular or more square, respectively.In other embodiments, the width W2 can be increased or reduced toprovide a shape that is more square or more rectangular, respectively.

The location of the lobes 158 can also be varied. Length L3 is thelength between the center of two apertures 162 which are both located onthe same side of the short axis C, and width W3 is the width between thesame apertures 162. In some embodiments, length L3 can be increased tocreate a shape that is more diamond-like. In other embodiments, lengthL3 can be reduced, which results in a shape that is less like aparallelogram. In some embodiments, length L3 can be reduced to zerosuch that the two apertures 162 are axially aligned along the short axisC, that is, both apertures 162 are the same distance from the short axisC. In some embodiments, the width W3 can be increased to create a shapethat is more like a square. In other embodiments, width W3 can bereduced, which results in a shape that is more like a rectangle.

The location of each aperture 162 within its lobe 158 relative to thelobe edge 160 can also be modified. In some embodiments, each aperture162 can be disposed closer to its respective lobe edge 160, while inother embodiments, each aperture 162 can be disposed farther from itsrespective lobe edge 160. In still other embodiments, the positions ofthe apertures relative to their respective lobe edges 160 may be mixedand matched, as may be desirable based on a variety of factors, such asfor example, if plate 150 is made as a custom patient-matched implantthat necessitates an altered configuration.

With reference to FIG. 6, S1 is the shape of the periphery of plate 150along the C axis. S2 is the shape of the periphery of plate 150 alongthe A axis. These shapes S1, S2, are depicted as concavities on theperiphery of plate 150. S1, S2 may be complexly formed splines createdfrom transitions of radii of different lengths, or shaped in any otherway known in the art, including having no curvature and being straight.In some embodiments, the concavities of S1 and S2 may be grosslyexaggerated toward the center of the plate 150, thus resulting in therebeing less plate 150 material. In other embodiments, one or both ofshapes S1 and S2 may be convexities.

As will be evident to those skilled in the art, there are a myriad ofpossible configurations of plate 150. This further facilitates thecustomizability of plate 150. For instance, plate 150 may be providedwith greater or lesser L3 and W3 dimensions so as to provide more orless distance, respectively, between the apertures 162. Similarly,others of the foregoing dimensions may be arranged to provide an alteredplate 150 according to the surgeon's preference or the particularpatient's needs. In some embodiments, various dimensions may be modifiedtogether to alter various aspects of plate 150, such as the locations oflobes 158 relative to perimeter edge 156.

For the foregoing description, it should be understood that, whilevarious lengths and widths were depicted on only one side of axis A or Cin FIG. 6, such depiction was made for clarity and efficiency ofexplanation only, and is not meant to be limiting. As such, for anyparticular length or width described, the same aspects and dimensions onthe opposite side of axis A or C exist and can be modified as describedabove. It should further be understood that the foregoing dimensions donot need to be symmetrical and can be varied from one side of axis A orC relative to the other side of axis A or C, respectively.

Continuing to refer to FIGS. 6-12, plate 150 may include a projection180 that extends generally orthogonally away from first side 152 ofplate 150. The purpose of projection 180 is to enable plate 150 to beconnected to a rod 100. Projection 180 includes an inner opening 182which may be configured to receive a first end 104 or second end 106 ofthe rod 100 of FIGS. 2-4, and also includes an external face 184 (FIG.10). In an embodiment, inner opening 182 may be formed with internalthreads 186 to communicate with external threads 140 of projection 138of rod 100 (see FIGS. 2 and 11). In some embodiments, inner opening 182is a blind bore (see, for instance, FIGS. 7 and 9), while in otherembodiments, inner opening 182 may extend completely through projection180. In still other embodiments, inner opening 182 may be unthreaded,and the connection between opening 182 and rod 100 may be a Morse-tapertype connection.

With reference to FIGS. 2 and 11, as will be evident to those skilled inthe art, during assembly of rod 100 to plate 150, as rod 100 is insertedinto opening 182 to a sufficient depth, the shoulder 142 of rod 100 willcontact face 184 of projection 180 of plate 150, thereby halting themovement of rod 100 into projection 180 and ensuring that rod 100 doesnot pass beyond projection 180.

In still other embodiments, plate 150 and, optionally, rod 100 may beconfigured with other structures or mechanisms known in the art thatfacilitate connection of plate 150 to a rod 100.

Referring to the exemplary embodiment of FIG. 12, rod 100 does not havethreads 140 on its projection 138 but has a through-hole 178 passingtransversely through projection 138. Plate 150 is provided with apartially threaded transverse hole 170 having threads proximal to secondside 154 of plate 150. Transverse hole 170 is configured to receive apartially threaded screw 176 and threadably communicate with screw 176in the region shown as 172. After rod 100 is inserted into opening 182of projection 180, rod 100's through-hole 178 is axially aligned withtransverse hole 170. Optionally, this alignment may be furtherfacilitated by having cooperating keyed surfaces on projection 138 andopening 182, as is known in the art. Then, screw 176 is inserted intohole 170 and through rod 100's through-hole 178, and threadably fixed toplate 150 at region 172. A portion of hole 170 may be countersunk, orotherwise formed, to accept in whole or in part, a head of a fastener,such as head 174 of screw 176, to enable head 174 to be countersunk intothe projection 180 of plate 150.

Referring to FIGS. 6-8 and 11, opening 182 in projection 180 of plate150 is formed around longitudinal axis D (FIG. 7). In this embodiment,axis D is in the same plane as axis A, which plane is defined by thecross-section line 11-11. Axis D travels through point P which is apoint in space within opening 182. Line E is a reference line drawnparallel to axis A of plate 150, and offset from axis A by virtue ofalso traveling through point P. As better seen in FIG. 11 where rod 100is assembled with plate 150, angle α, which is the angle between axis Dand line E, represents the angle between rod 100 and plate 150. Angle αmay range anywhere from about 5° to about 30° with reference to line E,or may be any other angle that may suit various clinical needs, as isevident to those skilled in the art. In an alternate embodiment (notshown), angle α may even be a negative angle, and in such case, plate150 would be shaped to accommodate rod 100 projecting through and aboveits second side 154. For example, plate 150 may have an opening throughits thickness T to accommodate rod 100, or perimeter edge 156 of plate150 may be concavely shaped so as to make room for rod 100 to passadjacent to plate 150.

In other alternative embodiments, the orientation of rod 100 to plate150 may be different. For example, axis D may be oriented at an angle tothe plane formed by cross-section line 11-11. This is depicted in FIG. 6with reference to axis D′. Axis D′ is depicted at angle β relative toaxis A. Angle β, like angle α, represents the angle of rod 100 to plate150 when they are assembled together. Of course, many other alternativeconfigurations are envisioned.

It is further envisioned that to accomplish the angulation of rod 100 toplate 150, opening 182 in projection 180 may be designed at differentangles as discussed above. Or as will be apparent to those skilled inthe art, projection 180, itself, may be designed on plate 150 atdifferent angles and configurations.

Optionally, plate 150 may be flat, as in FIG. 7 for example, or curved,as in FIG. 9. The curvature of plate 150 in FIG. 9 is along long axis A.However, as will be readily apparent to those skilled in the art, manyother curves and shapes of plate 150 are possible, as dictated bydifferent considerations such as manufacturability, or various clinicalfactors such as anatomical configurations of specific patients.Furthermore, it is contemplated that plate 150 may be provided as arigid, non-bendable plate, or alternatively, as a deformable plate,enabling intra-operative bending, as needed.

Plate 150 may be formed of any one or more suitable biocompatiblematerials known in the art, such as titanium, PEEK or otherbiocompatible materials having mechanical properties suitable for thecontemplated uses of plate 150. Plate 150 may also be coated in whole,or in part, with any suitable biocompatible material coating known inthe art.

For ease of reference, when rod 100 is assembled with plate 150, thismay also be referred to as a rod-plate construct, and so the rod-platesystem 50 may be comprised of one or more rod-plate constructs.

FIGS. 13 and 14 depict an embodiment of the rod-plate system 50, in thiscase comprising multiple rod-plate constructs implanted in a human foot.Of course, it is readily recognized that the number of rod-plateconstructs needed for a particular patient may be determined by thesurgeon.

In use, implantation of a rod-plate construct may begin by firstaligning and preparing each of the targeted bones for fusion. Anappropriately sized opening into the medullary canal of a targetedmetatarsal is made on its dorsal aspect at its midportion. A guidewireis then passed through the opening, through the medullary canal, andcontinues through the other bones to be fused. Optionally, the guidewiremay be passed through to the talus or calcaneus. An appropriately-sizedcannulated drill is then passed over the guidewire and used to create apassage within the bones to receive rod 100.

Rod 100, having the selected and corresponding length to that of thedrilled passage, is connected to plate 150. The second end 106 of rod100 is then inserted into the opening and through the passage untilprojection 180 of plate 150 comes to rest within the dorsal aspectopening in the metatarsal. Optionally, plate 150 may be shaped toconform to the topography of the metatarsal after insertion, orbeforehand. In other embodiments, a rigid pre-contoured plate 150 may beused. Once the rod-plate construct is in place, fasteners, such asscrews 164, are then used to fixedly connect plate 150 to themetatarsal.

FIGS. 15-17A depict an exemplary embodiment of shaft system 60 which isa subsystem of internal fixation system 40. Shaft system 60 may be usedindependently, or in conjunction with other systems, to facilitate thealignment, reduction and fixation of bones.

The prominent component of shaft system 60 is shaft 200. Shaft 200 maybe a unitary device, or a modular one comprised of various segments thatmay be joined together, thus enabling customization of shaft 200. Withspecific reference to FIG. 15, shaft 200 is modular, and is comprised ofsegments referred to as cap 202, intermediate spacer 204 a, intermediatespacer 204 b, and base 206. These segments may each be joined to eachother at a connection 203 (shown joined in FIGS. 16-17A). Connection 203may be a threaded connection, a Morse-taper type connection, or anyother suitable connection known in the art. It is further understoodthat one or more different types of connections 203 may be used toassemble shaft 200.

Cap 202 is a hollow body comprising a bore 215. Cap 202 furthercomprises a first end 210 having a rounded terminal portion 214 whichfacilitates shaft 200's insertion into bone during implantation, and asecond end 212 where bore 215 has internal threads 216 to enable cap 202to be connected to another mateable segment of shaft 200. Cap 202further has a transverse through-hole 218 to receive fixation element220 (FIG. 16) to fix cap 202, and thereby facilitate fixing shaft 200,to bone. More detail about the optional configurations and uses ofthrough-hole 218 will be discussed in more detail later with referenceto base 206.

Intermediate spacers 204 a and 204 b each have similar configurationswith the difference being that spacer 204 a includes through-hole 218,while spacer 204 b does not have any such through-holes. Both spacers204 a, 204 b further have a first end 222, an opposite second end 224,and bore 215 extending therebetween, thereby making them hollow. Onfirst end 222, there is a projection 225 with external threads 226.External threads 226 are configured to mate with internal threads 216,to enable a secure connection 203 therebetween, and thus between any onespacer 204 a, 204 b and cap 202. As is evident from this description,the intention is to enable the easy interchangeability andinterconnectability of different segments.

Base 206 also has a first end 232, an opposite second end 234, and bore215 extending therebetween, thereby making it hollow. On its first end232, base 206 has a similar projection 225 with external threads 226 asdiscussed above with reference to other segments, for purposes ofinterchangeability. Base 206 is also depicted with through-hole 218 toenable its connection to bone. At its second end 234, base 206 also hasa slot 240 therethrough to facilitate bringing two bone segmentstogether, otherwise known as reduction, as will be discussed in moredetail below. Lastly, base 206 has internal threads 248 at its secondend 234. These internal threads 248 are configured to cooperate withexternal threads 226 of the various segments, as well as with externalthreads 256 of plug 208. Notably, internal threads 248 may run deeperinto bore 215 of base 206 than comparable internal threads 216 in othersegments. This is because internal threads 248 are also configured toreceive plug 208.

Plug 208 comprises body 255 with external threads 256 that are similarto external threads 226 on the other segments of shaft 200, again forinterchangeability, a compression element 260, and an instrumentengagement area 265. The insertion of plug 208 into the second end 234of base 206, and its movement through bore 215, together with slot 240,and the use of a fastener 242 (FIG. 16), enables reduction, as will bediscussed yet further in more detail below.

With reference to FIGS. 16-17A, in order to perform reduction, onesegment of bone must be stationary, and an adjacent segment of bone mustbe moved toward the stationary bone segment. In the present embodiment,bone B1 is the stationary bone. Shaft 200 is fixed to bone B1 with screw220 positioned through through-hole 218 in base 206. Notably,through-hole 218 also provides for further variability of fixationmethods of shaft 200 to bone as discussed next.

It is recognized that there are at least two common approaches tofixating shaft 200 in space relative to bone, among various otherapproaches known in the art. In one such common approach, this isaccomplished by fixing proximal bone portion Bp to shaft 200. In theother common approach, this is accomplished by pinning shaft 200 inbetween two segments of bone.

With reference to the first approach, when shaft 200 is in a bone canal(FIG. 17), a bore 230 is drilled from the proximal bone surface Bp ofproximal bone B1 to the exterior of shaft 200. Bore 230 is coaxial withthrough-hole 218 and sized to allow the head of screw 220 to pass. Screw220 is then inserted through bore 230 and threaded into a threadedversion of through-hole 218. As is evident, and known in the art, it isnot necessary for screw 220 to go all the way through base 206, so longas there is sufficient threaded engagement in the first area of contactbetween screw 220 and base 206. Of course, if more thread engagement isdesired, screw 220 may be progressed further to threadably engage base206 at its second area of contact with base 206. As will be readilyrecognized, the approach just described from bone surface Bp may besimilarly accomplished from the opposite distal bone surface Bd. Forthis reason, it is desirable to have through-hole 218 fully threaded.

With respect to the second approach of fixating shaft 200 in spacerelative to bone, the intention is for screw 220 to enter through bore230, completely extend through shaft 200, and threadably purchase boneportion Bd. While this approach may better call for through-hole 218 tobe unthreaded, to increase the variability of usage of shaft 200, thethreaded version of through-hole 218 may continue to be employed. Ofcourse, having described the foregoing, it will be readily recognizedthat various alternatives and permutations of the above configurationsof structure and usage may be employed. Additionally, it is noted thatthrough-hole 218 has the same characteristics as through-hole 130 of rod100.

With further reference to FIGS. 16-17A, in the context of reduction, thebone segment that will be moved toward stationary bone segment B1 ismovable bone segment B2. Of course, it is generally recognized thatmovement is relative. In similar fashion as described for putting screw220 through through-hole 218 of base 206, a partially threaded screw 242is put through slot 240, and specifically through slot area 244 which ismost distal to base 206's first end 232, and screwed into bone B2. Plug208 may be introduced into threaded engagement with internal threads 248of second end 234 of base 206 before or after insertion of screw 242,and positioned at slot area 244.

A driver (not shown) is then engaged to plug 208's instrument engagementarea 265, and actuated so as to rotate plug 208 in direction F (FIG.17A), thus translating plug 208 towards slot area 246 by virtue of thetranslational component of threaded rotation. In so doing, compressionelement 260 of plug 208 pushes screw 242 linearly along slot 240 fromslot area 244 to slot area 246, a distance M. Consequently, this pushesbone segment B2 towards bone segment B1, which is fixedly connected tobase 206 via through-hole 218, the same distance M, thus producingreduction.

It will be readily understood by those skilled in the art that thereduction mechanism described above, inclusive of such elements as slot240 and plug 208, may be positioned on any other one or more segments ofshaft 200 for increased variability of the segments of shaft 200. Ofcourse, other means to rotate or otherwise advance plug 208 may beneeded in instances where its instrument engagement area 265 is notaccessible as in the embodiment described above.

While slot 240 has been described in the context and functionalitydepicted with reference to shaft 200, a somewhat similar slot 132 ispositioned on rod 100 (FIG. 5) as mentioned earlier. The specificmechanism for reduction using slot 132 will be different from thatdescribed for slot 240, but such other ways to perform reduction areknown in the art. For example, with reference to FIG. 24, if a pin 310were inserted through slot 132 of rod 100 into one bone, and a screw 220were inserted through hole 130 of rod 100 into another bone, then asurgeon may manually grip and translate pin 310 and screw 220 towardeach other, thereby bringing the two bones together.

The ability to rotationally align one segment of shaft 200 to a desiredposition relative to another segment of shaft 200, for a variety ofpurposes, is an engineering function that has many different solutionsknown in the art. For example, with reference to FIG. 16, it may bedesirable to have through-hole 218 on cap 202 oriented 30° in eitherdirection from where it is shown. Similarly, on the same shaft 200, itmay be desired for through-hole 218 on spacer 204 a to be oriented 15°from where it is shown. One way to accomplish such desired alignment ofthrough-holes 218 in an assembled shaft 200 is to have keyed, timed, orprecision threads 216, 226 that enable planned rotational assembly toresult in the desired alignment.

The ability to target and insert screws 220, 242 into their respectivepositions in or through rods 100 and shafts 200 is also an engineeringfunction that has various different solutions known in the art. Forexample, targeting jigs are known to facilitate the location andidentify the orientation of through-holes 218 when shaft 200 is insidebone. Rods 100 and shafts 200 may be configured to cooperate with suchtargeting jigs.

As was noted earlier with respect to rod 100, shaft 200, and the variousother elements described above, may be formed of any suitable materialknown in the art. For example, shaft 200 may be formed of titanium, orother biocompatible materials having mechanical properties suitable forits contemplated uses. Furthermore, shaft 200 may be coated with anysuitable biocompatible coating known in the art, such as hydroxyapatiteor the like, or may be uncoated, as needed to suit particular mechanicaland clinical needs.

Notably, as will be apparent to those skilled in the art, shafts 200 maybe solid rather than hollow, and rods 100 may be hollow rather thansolid. Of course, various other adjustments to their respective featuresmay then be made to result in those features maintaining theirrespective intended functionalities. For example, if shaft 200 weresolid rather than hollow, second end 234 of base 206 would stillmaintain a hollow passageway to enable plug 208 to travel therethroughto effectuate reduction.

Referring to FIGS. 18 and 19, two shafts 200 of shaft system 60 areshown implanted in a human foot. The medial shaft 200 is assembled froma cap 202, followed by two spacers 204 a, and then a base 206, and isoriented such that base 206 is located in the first metatarsal, and thecap 202 is in the talus. The lateral shaft 200 is assembled from anothercap 202 and a base 206. It is oriented such that base 206 is in thecalcaneus, and cap 202 is in the cuboid. Each shaft 200 is depicted asfixed in place to bone by various screws 220, 242.

Each of the bones targeted for fusion are first manually aligned andprepared for accepting shaft system 60. For example, to implant themedial shaft 200, the first metatarsal phalangeal joint is exposed via adorsal incision. A guidewire to direct reaming of the medullary canal isthen introduced near the center of the metatarsal head, directed throughthe metatarsal body, medial cuneiform navicular, and into the talarneck. Reaming is then conducted iteratively over the guidewire until acanal having an appropriate internal diameter to receive shaft 200 isformed through the bones. Of course, it is recognized that variousanatomical landmarks and sizes of bones will ultimately determine theselection of the diameter and length of the canal, and therefore thediameter and length of shaft 200 to be used in it, as well as whichsegments of shaft 200 should be selected and the order in which theyshould be assembled.

Prior to insertion of shaft 200, it may be connected to a targeting jig(not shown). The targeting jig projects the positions of the relevantthrough-holes on shaft 200, such as holes 218, and thus enables asurgeon to accurately place screws 220 through the targeting jigdirectly into or through each targeted hole 218, for example, as thecase may be, after shaft 200 is placed in the reamed bone canal.

Once the targeting jig is attached to the medial shaft 200, medial shaft200 is then inserted into the reamed bone canal. A screw 220 is thenplaced through the jig and through hole 218 of cap 202 which is locatedin the talus. Then, screw 242 is placed through the jig and through slot240, which, in such embodiment, is in the first metatarsal. Plug 208,located in second end 234 of base 206 is then rotationally actuated totranslate axially along slot 240, thus compressing all the bones betweenscrew 242 and screw 220 along shaft 200, to a desired orientation, atwhich point, other screws 220 will be inserted through shaft 200 to lockthe compressed bones in place relative to shaft 200. Alternatively, someor all of the compression may also be performed by other techniquesknown in the art.

In light of the foregoing, the preparation of bones, the selection,assembly, and insertion of lateral shaft 200, and the reduction andfixation of the associated bones, will be apparent to those skilled inthe art.

With reference to FIGS. 20-21, there is depicted the implantedcombination of a rod-plate system 50 and shaft system 60. Specifically,there are two rod-plate constructs, and two shafts 200. Notably, a rod100 may be connected to a shaft 200, and is depicted as such. This maybe accomplished using screw 220, or by other means. As will be apparentto those skilled in the art, any number, combination, and configurationof rod-plate constructs and shafts may be employed, and also connectedto each other at different points, as necessary to address variousclinical needs.

FIG. 22 depicts a midfoot component in the form of plate 280, havingscrew holes 281 adapted to receive screws 282 (FIG. 23) that attachplate 280 to bone. Plate 280 is generally known in the art. Plate 280may be malleable, to enable it to be shaped in situ to conform to targetanatomy to which it will be attached, or provided in multiple genericrigid shapes, or otherwise custom manufactured through patient-matchingtechnologies. It is intended to be used on its own, or in combinationwith one or more systems and subsystems of fixation system 10.

FIG. 23 depicts plate 280 implanted in a foot in combination withrod-plate constructs and shafts 200, wherein certain of the rods 100 andshafts 200 are interconnected. The possibility to combine all thesesubsystems offers increased variability and flexibility to treat agreater variety of clinical needs.

FIG. 24 depicts an internal fixation subsystem, namely shaft system 60,connected to an external fixation system 80. External fixation system 80comprises one or more frames 302 each having a plurality of openings304, a plurality of connectors 306, and pins 310. Pins 310 are depictedas partially threaded on their distal ends, and may also optionally beunthreaded, or fully threaded, as is known in the art. This basicexternal fixation system 80 is also well known in the art.

Notably, an aspect of the present invention is the connection ofexternal fixation system 80 to the shaft system 60, as depicted in FIG.24. Specifically, frame 302 is connected using pins 310 inserted throughconnectors 306 to shafts 200. It is thusly evident that many otherconfigurations, arrangements and connections of external fixation system80 with one or more of certain subsystems of internal fixation system 40are possible. For example, external fixation system 80 may be connectedto an implanted rod-plate system 50.

The added ability to combine and connect external fixation system 80with the various subsystems of internal fixation system 40 increases yetfurther the variability and flexibility of the overall fixation system10 to treat a yet greater variety of clinical needs.

FIG. 25 depicts a sole component 400 of external fixation system 80.Sole component 400 is intended to be used in conjunction with externalfixation system 80 and is meant to provide a weight-bearing platformunderneath a patient's foot to enable a patient with fixation system 10to walk.

Sole 400 comprises a housing 402 adapted to hold a removable liner 404therein. With reference from front 410 to back 412, housing 402 has atop surface 406, side walls 407 and a bottom surface 408 that spanshousing 402 from front 410 to back 412. Bottom surface 408 is thesurface that comes in contact with the ground when a patient walks whilewearing fixation system 10. As such, its shape, texture and materialsmay be adapted as known in the art to facilitate safer walking. Forexample, bottom surface 408 may be made of, or coated with, rubber toincrease the coefficient of friction between sole 400 and the ground,thus diminishing the chances of a patient slipping while they walk withfixation system 10. Other embodiments are envisioned to accomplish thisgoal.

The profile of bottom surface 408 may be a complex series of continuouscurves, such as a tighter curve toward the back 412, which may be knownas the heel-strike area, eventually transitioning to a gradual curvetoward the front 410, over which the forefoot rolls during gait. Ofcourse, other shapes are contemplated.

Liner 404 may include an inflatable air bladder (not specifically shown)and be filled with any appropriate fluid. The bladder may have a valve(not specifically shown) through which air or other fluid may beintroduced or evacuated to achieve the optimal density and size tosupport a particular weight or pressure requirement. Liner 404 mayoptionally be housed in a fabric shell (not specifically shown). Theshell can be moisture wicking and machine washable for easy cleaning andmaintenance. The shell may also be removable via a zipper, hook-and-loopfasteners, snaps, and the like.

Sole 400 also has slots 424, enabling it to be connected to frame 302(FIG. 26), as will be discussed in more detail below. Slots 424 may beformed within the material of housing 402, or may alternatively be solidtubes affixed to either the inside or outside of housing 402, as may bereadily understood by those skilled in the art.

FIG. 26 is an exploded view of certain components of external fixationsystem 80 used to assemble sole 400 to frame 302. More specifically,connectors 306 have threaded openings 307 on their various faces,enabling them to be connected to frame 302 and to other components usingbolts 308, thus making them universal.

Struts 426 are used to connect sole 400 to frame 302. Struts 426 haveeyelets 428 to enable such a connection. For example, after connectors306 are connected to frame 302 with bolts 308, eyelets 428 of struts 426would be aligned with connectors 306, and additional bolts 308 would beput through eyelets 428 and screwed into connectors 306, thus pinningand fixing struts 426 to frame 302. Struts 426 shall also be connectedto sole 400 in any variety of ways known to those skilled in the art.For example, struts 426 may be inserted and glued into slots 424.

Struts 426 may be of unitary construction, or alternatively, may becomprised of two or more components enabling strut 426 to expand andcompress as well as be fixed in place at a desired length. Struts 426may also be made from various materials, from stiff metals, to moreelastomeric materials that may further facilitate absorption of strikingforces during gait.

Having thus described the invention in detail, it is to be understoodthat the foregoing description is not intended to limit the spirit orscope thereof. It will be understood that the embodiments of the presentdisclosure described herein are merely exemplary and that a personskilled in the art may make any variations and modification withoutdeparting from the spirit and scope of the disclosure. All suchvariations and modifications, including those discussed above, areintended to be included within the scope of the disclosure.

What is claimed is:
 1. A fixation system for immobilizing a skeletalstructure, comprising: an internal fixation system comprising one ormore of a rod-plate system, and a shaft system; and an external fixationsystem; wherein the rod-plate system comprises a rod affixed to a plate,the rod being adapted to be positioned in a bone canal, and the platebeing adapted to be positioned on bone near the bone canal; wherein theshaft system comprises a shaft with a longitudinal axis, a slot on theshaft oriented in the direction of the longitudinal axis, and a hole onthe shaft oriented at an angle to the longitudinal axis, the shaftfurther adapted to be positioned in a bone canal and configured to movetwo bone segments that comprise the bone canal toward each other; andwherein the external fixation system comprises a frame connected to asole, the sole having a bottom adapted to contact ground.
 2. Thefixation system of claim 1, wherein the external fixation system furthercomprises a pin, and the external fixation system is connected to therod-plate system or the shaft system via the pin, and the rod-platesystem or the shaft system is located in bone.
 3. The fixation system ofclaim 1, wherein the rod-plate system is connected to the shaft systemwhen both systems are located in bone.
 4. The fixation system of claim3, further comprising a midfoot plate system attached to bone, themidfoot plate system comprising a plate and a fastener.
 5. The fixationsystem of claim 1, wherein the rod of the rod-plate system is modularlycomprised of multiple segments each joinable by a connection.
 6. Thefixation system of claim 5, wherein the connection is a threadedconnection or a Morse-taper connection.
 7. The fixation system of claim1, wherein the plate of the rod-plate system comprises a first sideadapted to face bone, an opposite second side, a length, a width, aplate axis along the length, and a projection extending from the firstside.
 8. The fixation system of claim 7, wherein the projection includesan opening to communicate with the rod of the rod-plate system.
 9. Thefixation system of claim 8, wherein the opening in the projectioncommunicates with the rod via a threaded connection.
 10. The fixationsystem of claim 8, wherein the opening is cylindrical and has alongitudinal opening axis, and the opening is oriented such that theopening axis is at an angle to the plate axis.
 11. The fixation systemof claim 1, wherein the shaft of the shaft system is modularly comprisedof multiple segments each joinable by a connection.
 12. A fixationsystem for immobilizing a skeletal structure, comprising: an internalfixation system having a rod-plate system, and a shaft system; and anexternal fixation system; wherein the rod-plate system comprises a rodaffixed to a plate, the rod being adapted to be positioned in a bonecanal, and and the plate being adapted to be positioned on bone near thebone canal, the plate further having a first side adapted to face bone,an opposite second side, a length, a width, a plate axis along thelength, and a projection extending from the first side, the projectionhaving a cylindrical opening with a longitudinal opening axis, and theopening being oriented such that the opening axis is at an angle to theplate axis; wherein the rod-plate system is connected to the shaftsystem with a fixation element when both systems are located in bone;and wherein the external fixation system is connected to one of therod-plate system or shaft system.
 13. The fixation system of claim 12,wherein the rod of the rod-plate system is modularly comprised ofmultiple segments each joinable by a connection.
 14. The fixation systemof claim 13, wherein the connection is either a threaded connection or aMorse-taper connection.
 15. The fixation system of claim 12, wherein theexternal fixation system further comprises a pin, and wherein the pinconnects the external fixation system to one of the rod-plate system orshaft system.
 16. The fixation system of claim 15, wherein the externalfixation system further comprises a frame connected to a sole, the solehaving a bottom adapted to contact ground.
 17. The fixation system ofclaim 12, further comprising a midfoot plate system attached to bone,the midfoot plate system comprising a plate and a fastener.
 18. Afixation system for immobilizing a skeletal structure, comprising: aninternal fixation system comprising one or more of a rod-plate system,and a shaft system; and an external fixation system; wherein therod-plate system comprises a rod affixed to a plate, the rod beingadapted to be positioned in a bone canal, and the plate being adapted tobe positioned on bone near the bone canal; wherein the shaft systemcomprises a shaft with a longitudinal axis, a slot on the shaft orientedin the direction of the longitudinal axis, and a hole on the shaftoriented at an angle to the longitudinal axis, the shaft further adaptedto be positioned in a bone canal and configured to move two bonesegments that comprise the bone canal toward each other; and wherein theexternal fixation system comprises a frame connected to a sole, the solehaving a housing and a bottom adapted to contact ground, the housingcontaining a liner.
 19. The fixation system of claim 18, wherein theliner comprises an inflatable bladder in a shell.
 20. The fixationsystem of claim 18, wherein the sole is connected to the frame withadjustable struts.